The following data is part of a premarket notification filed by Optomed Oy with the FDA for Optomed Smartscope M5 Ey3 And M5 Es1.
| Device ID | K110986 |
| 510k Number | K110986 |
| Device Name: | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPTOMED OY HALLITUSKATU 13-17 D 96 Oulu, FI 90100 |
| Contact | Laura Piila |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-08 |
| Decision Date | 2011-05-16 |
| Summary: | summary |